Efficacy of Vitamin D3-fortified-yogurt Drink on Anthropometric, Metabolic, Inflammatory and Oxidative Stress Biomarkers According to Vitamin D Receptor Gene Polymorphisms in Type 2 Diabetic Patients: a Study Protocol for a Randomized Controlled...

Overview

Journal BMC Endocr Disord

Publisher Biomed Central

Specialty Endocrinology

Date 2011 Jun 24

PMID 21696575

Citations 8

Authors

Sakineh Shab-Bidar

Tirang R Neyestani

Abolghassem Djazayery

Affiliations

Soon will be listed here.

Abstract

Background: Development of type 2 diabetes mellitus (T2DM) is determined by the interactions of genetic and environmental factors. This study was designed to evaluate the possible role of VDR single nucleotide polymorphisms (SNPs) on different aspects of diabetic host response (anthropometric, metabolic, oxidative stress and inflammatory) to daily intake of vitamin D through fortified yogurt drink for 12 weeks.

Methods/design: This study comprises two parts: (i) a case-control study; and (ii) an intervention trial. In the first part, VDR polymorphisms (Taq1, FokI, Apa1, Bsm1, and Cdx2) are determined in 350 T2DM patients and 350 non-diabetic subjects. In the second part, the possible effects of daily intake of two servings of vitamin D3-fortified yogurt drink (FYD; 500 IU vitamin D/250 mL) on some selected metabolic (including insulin resistance), inflammatory and oxidative stress biomarkers in 135 T2DM patients are assessed. To relate the resulted changes in the biomarkers to vitamin D replenishment, another group of diabetic patients (n = 45) are also included in the study who receive 2 servings of plain yogurt drink (PYD) a day. The primary outcome is serum level of 25(OH) D, which it is expected to be elevated only in FYD group. Secondary outcomes include improvements in glycemic, metabolic, inflammatory and oxidative stress biomarkers in FYD group compared to PYD group. Three VDR FokI polymorphisms are determined only in FYD group followed by comparison of changes in the biomarkers among these genotypic variants.

Discussion: The present study, at least in part, elucidates the discrepancies in the results of different vitamin D-diabetes studies pertaining to the genetic variations of the population. If VDR polymorphisms are found to influence the response to our intervention, then knowing distribution of VDR polymorphisms in both diabetic and non-diabetic populations can give a picture of the proportion of the community in whom up to 1000 IU/d vitamin D may not be effective enough to improve insulin resistance and related morbidities. Therefore, they should ideally receive further nutritional support according to their genotype.

Trial Registration: ClinicalTrials.gov: NCT01236846.

Citing Articles

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Attenuation of Oxidative Stress, Interleukin-6, High-Sensitivity C-Reactive Protein, Plasminogen Activator Inhibitor-1, and Fibrinogen with Oral Vitamin D Supplementation in Patients with T2DM having Vitamin D Deficiency.

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Comparing the effectiveness of vitamin D plus iron vs vitamin D on depression scores in anemic females: Randomized triple-masked trial.

Vafa M, Azizi-Soleiman F, Kazemi S, Salehi M, Zaeri F, Abiri B Med J Islam Repub Iran. 2019; 33:64.

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Consumption of vitamin D-fortified yogurt drink increased leptin and ghrelin levels but reduced leptin to ghrelin ratio in type 2 diabetes patients: a single blind randomized controlled trial.

Hajimohammadi M, Shab-Bidar S, Neyestani T Eur J Nutr. 2017; 56(6):2029-2036.

PMID: 28229278 DOI: 10.1007/s00394-017-1397-z.

The interactive effect of improvement of vitamin D status and VDR FokI variants on oxidative stress in type 2 diabetic subjects: a randomized controlled trial.

Shab-Bidar S, Neyestani T, Djazayery A Eur J Clin Nutr. 2014; 69(2):216-22.

PMID: 25424601 DOI: 10.1038/ejcn.2014.240.

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